BEUDAMED
    FDA Recall Terminated

    Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE

    Recall: Z-0468-03 · Initiated December 20, 2002

    Recall

    Recall Number
    Z-0468-03
    Event Number
    25265
    Firm
    Megadyne Medical Products, Inc
    FEI Number
    1721194
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2002
    Posted
    January 30, 2003
    Terminated
    September 5, 2003
    Address
    11506 South State Street, Draper, UT, 84020

    Description

    Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE

    Reason

    The metal substrate cautery tip may break during use.

    Action

    On 12/20/2002, all consignees were notified by letter to return all affected product.

    Distribution

    Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.

    Quantity

    19464